Healthcare Industry News: Shire Pharmaceuticals
News Release - March 5, 2007
UK Launch Expands Global Reach of FOSRENOL(R)New Option for Effective Control of Phosphate Levels and Potential to Lower Pill Burden Now Available for Patients With End Stage Renal Disease
BASINGSTOKE, England, March 5 (Healthcare Sales & Marketing Network) - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ). Shire recently announced the launch of FOSRENOL (lanthanum carbonate) in the United Kingdom (UK) following the product's successful approval for the control of hyperphosphataemia in patients with chronic kidney disease (CKD) on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
FOSRENOL is an effective treatment for the control of hyperphosphataemia in patients with CKD on dialysis.(2) FOSRENOL has a high affinity for phosphate (in vitro data)(3), and therefore in the patients with CKD FOSRENOL binds to dietary phosphate to effectively reduce serum phosphorus levels. FOSRENOL is well tolerated and the majority of patients require just one chewable tablet taken during each meal.(4)
Dr David Goldsmith, Consultant Nephrologist at Guy's and St Thomas' Hospitals in London welcomed news of this launch and explained, "Effective control of hyperphosphataemia remains a difficult problem for many patients on dialysis, with many patients still having phosphate levels above the recommended upper limit of 1.78 mmol/L. The introduction of FOSRENOL in the UK offers patients a new, effective therapy with the added potential benefit of a reduced pill burden, which may help to simplify the management of their phosphate levels."
Over 5,000 patients have been treated with FOSRENOL during an extensive clinical development programme,(5) with a small number having now received treatment for up to six years.(6) This launch extends the availability of FOSRENOL which is now available in Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Korea, The Netherlands, Sweden, Taiwan and the US.
"Shire is delighted with the introduction of FOSRENOL in the UK adding to recent successful launches into Germany and France, which have helped to extend the availability of this important new product across Europe," said David Milton, Senior Vice President, Shire Renal Business Unit. "Effective control of serum phosphate levels is seen as complex and challenging for patients with CKD who are already taking a number of different therapies for their condition. FOSRENOL provides an effective new treatment option helping to make control of phosphate levels simpler and easier. We hope the UK launch will continue to build on the success FOSRENOL has achieved in the US, where it has already benefited thousands of CKD patients."
Hyperphosphataemia is an almost inevitable consequence of CKD due to the inability of failing kidneys to effectively rid the body of excess phosphate that enters the body during daily dietary intake.
If not managed successfully, hyperphosphataemia can cause unpleasant symptoms such as intense itching and in the long-term patients face serious health risks including renal osteodystrophy, a bone disorder resulting in painful, brittle bones that may fracture or lead to deformities.(7) Surveys of medical records have shown that high phosphate levels are also linked with cardiovascular disease, which accounts for almost half of all deaths among dialysis patients.(8)
To help manage their phosphate levels, dialysis patients are restricted to a low phosphate diet, which can be unpalatable and difficult to maintain.(9) Whilst dialysis can remove some of the ingested phosphate, it is insufficient alone for the majority of patients. Indeed, up to 75 per cent of dialysis patients exceed the Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for phosphate of 1.78 mmol/L (5.5 mg/dL).(10) Phosphate binder therapy is therefore an important and necessary part of achieving phosphate control.
Despite the availability of existing therapies, effective phosphate management remains a challenge. FOSRENOL provides physicians with an alternative treatment option to help effectively manage hyperphosphataemia in their dialysis patients.
1. Grassman A et al. ESRD patients in 2004: global overview of patient numbers, treatment modalities and associated trends. Nephrol Dial Transplant 2005; 20: 2587-2593.
2. Hutchison AJ et al. Long-term efficacy and tolerability of lanthanum carbonate: results from a 3-Year Study. Nephron Clinical Practice 2006; 102: 61-71.
3. Damment SJP, Webster I. The pharmacology of lanthanum carbonate (FOSRENOL(R)): a novel non-aluminum, non-calcium phosphate binder. Poster presented at 36th Annual Meeting of the American Society of Nephrology, San Diego, 14-17 November 2003.
4. Vemuri N et al. Lanthanum carbonate provides serum phosphorus control with a reduced tablet burden. Poster presented at ERA/EDTA, Glasgow, 15-18 July 2006.
5. Shire Data on File 08.2644.
6. Hutchison A et al on behalf of the SPD405-309 Lanthanum Study Group. Evidence for the long-term safety and tolerability of lanthanum carbonate. Poster presented at 38th Annual Meeting of the American Society of Nephrology, Philadelphia, 8-13 November 2005.
7. Martin K, Gonzalez A. Strategies to minimize bone disease in renal failure. Am J Kidney Dis 2001; 38: 1430-36.
8. Block G et al. Re-evaluation of risks associated with hyperphosphataemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis 2000; 35 (6): 1226-1237.
9. Malluche HH, Monier-Fugere M-C. Hyperphosphataemia: pharmacologic intervention yesterday, today and tomorrow. Clin Nephrol 2000; 54(4): 309-17.
10. Kim J et al. Achievement of proposed NKF-K/DOQI Bone Metabolism and Disease Guidelines: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). J Am Soc Nephrol 2003; 14: 269A.
Notes to Editors:
Phosphorus, an element found in nearly all foods, is absorbed from the gastrointestinal tract into the blood stream. When the kidneys fail, they no longer effectively filter out phosphates, even with the help of blood-cleansing dialysis machines. While the normal adult range for phosphorus is 2.5 (0.8mmol/L) to 4.5 mg/dL (1.4mmol/L), the blood phosphorus levels of many patients on dialysis exceed 6.5 mg/dL (2.1mmol/L). Such levels have been linked to a significantly higher illness and death risk for patients who have undergone at least one year of dialysis(i) with up to 75 per cent of patients developing hyperphosphataemia(ii). Hyperphosphataemia disrupts the delicate interplay between the body's levels of calcium, parathyroid hormone (PTH) and vitamin D. Over time, hyperphosphataemia can ultimately lead to calcification of the heart, lung and some arteries(iii). Accumulating evidence shows that hyperphosphataemia contributes to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients(iv). Studies have shown that cardiovascular mortality in dialysis patients aged 25-34 years is more than 5 times greater than that in people aged 65-74 in the general population(v).
Since dialysis and diet restrictions alone generally cannot control phosphate levels, patients traditionally manage hyperphosphataemia by taking phosphate binding agents with every meal and snack. Such binders "soak up" phosphate in the gastrointestinal tract, before it can be absorbed into the blood.
FOSRENOL(R) (lanthanum carbonate)
FOSRENOL(R) works by binding to dietary phosphate in the GI tract; once bound, the lanthanum/phosphate complex cannot pass through the intestinal lining into the blood stream and is eliminated from the body. As a consequence, overall phosphate absorption from the diet is decreased significantly. Shire has conducted an extensive worldwide clinical research programme for FOSRENOL involving over 5000 patients(vi), with a small number followed for up to 6 years.(vii) This programme has demonstrated that FOSRENOL is an effective phosphate binder with a good tolerability profile for long-term use. FOSRENOL was approved by the FDA in October 2004. In March 2005 regulatory authorities in the EU granted marketing authorization for FOSRENOL in sixteen member states, thus completing the first step in securing marketing approval throughout Europe. FOSRENOL has since been launched in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, The Netherlands, Poland and Sweden. The final step in the European process was recently completed resulting in recommendation for approval in the remaining 11 member states. Further roll-outs are underway across the rest of Europe and other countries around the world. The company has out-licensed the rights to develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd.
Patients with renal insufficiency may develop hypocalcaemia. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.
No data are available in patients with severe hepatic impairment. Caution should, therefore, be exercised in these patients, as elimination of absorbed lanthanum may be reduced.
FOSRENOL should not be used during pregnancy.
Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with Fosrenol.
The most commonly reported Adverse Drug Reactions (ADRs) ((greater than)1/100, 1/10) are gastrointestinal reactions such as abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting. These are minimized by taking FOSRENOL with food and generally abated with time with continued dosing. Hypocalcaemia was the only other commonly reported adverse reaction.
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD), MEZAVANT(TM) (SPD476) (mesalazine) in Europe, and VYVANSE(TM) (NRP104) (lisdexamfetamine dimesylate) (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.
Source: Shire PLC
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